FDA 510(k) Applications for Medical Device Product Code "DBF"
(Ferritin, Antigen, Antiserum, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K983759 ABBOTT LABORATORIES ABBOTT ARCHITECT FERRITIN 12/07/1998
K935847 ABBOTT LABORATORIES AXSYM FERRITIN 06/21/1994
K801676 ABBOTT LABORATORIES FERRIZYME FERRITIN ENZYME IMMUNOASSAY 08/20/1980
K974505 ALFA BIOTECH (UK) LTD. AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501 02/17/1998
K844158 AMERICAN DADE STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY 11/19/1984
K892362 AMERSHAM CORP. AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL) 05/09/1989
K874203 AMERSHAM CORP. AMERLITE FERRITIN ASSAY, LAN.0800/1800/2800 01/27/1988
K800657 AMERSHAM CORP. FERRITIN CONTROLS CODE QAS.104 04/16/1980
K800299 AMERSHAM CORP. FERRITIN RIA KIT 03/03/1980
K811804 AMERSHAM CORP. FERRITIN RIA KIT 07/10/1981
K895872 AMERSHAM CORP. LAN.0800Q/2800Q 10/17/1989
K982714 BAYER CORP. BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY 10/22/1998
K885074 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC AFFINITY(TM) FERRITIN IMMUNIT(TM) 01/04/1989
K870570 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC FERRITIN MAB SOLID PHASE COMPONENT SYSTEM 03/12/1987
K092505 BECKMAN COULTER, INC. BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203 12/11/2009
K983340 BECKMAN COULTER, INC. IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN CALIBRATOR 12/14/1998
K864437 BECKMAN INSTRUMENTS, INC. BECKMAN EPSILON(TM) FERRITIN TEST KIT 01/16/1987
K973202 BEHRING DIAGNOSTICS, INC. MODIFICATION OF OPUS FERRITIN TEST SYSTEM 09/12/1997
K950707 BEHRING DIAGNOSTICS, INC. N LATEX FERRITIN 03/27/1995
K863487 BIO-RAD QUANTIMUNE(R) FERRITIN IRMA 10/01/1986
K812901 BIO-RIA 125I FERRITIN RADIOIMMUNOASSAY KIT 12/30/1981
K992517 BIOCHECK, INC. BIOCHECK FERRITIN ELISA MODEL BC-1025 09/24/1999
K904822 BIOCLONE AUSTRALIA PTY LTD. ELEGANCE FERRITIN ELISA 11/29/1990
K860137 BOEHRINGER MANNHEIM CORP. ENZYMUN-TEST FERRITIN 03/28/1986
K992157 CHIRON DIAGNOSTICS CORP. CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY 08/05/1999
K905770 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING ACS FERRITIN IMMUNOASSAY 03/12/1991
K873573 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING MAGIC LITE FERRITIN 10/07/1987
K791860 CIS RADIOPHARMACEUTICALS, INC. FERRITIN RIA KIT 12/06/1979
K770702 CLINICAL ASSAYS, INC. IN VITRO FERRITIN RIA TEST 06/17/1977
K830591 CORNING MEDICAL & SCIENTIFIC CORNING FERRITIN 125I RADIOIMMUNOASSAY 03/24/1983
K812786 CORNING MEDICAL & SCIENTIFIC FERRITIN(125I) RADIOIMMUNOASSAY TEST SYS 10/23/1981
K993273 DADE BEHRING, INC. N LATEX FERRITIN 11/23/1999
K792442 DADE, BAXTER TRAVENOL DIAGNOSTICS, INC. FERRITIN RADIOIMMUNOASSAY 12/18/1979
K870107 DIAGNOSTIC PRODUCTS CORP. COAT-A-COUNT IRMA FERRITIN KIT AND ITS COMPONENTS 02/10/1987
K801580 DIAGNOSTIC PRODUCTS CORP. FERRITIN RIA KIT 08/13/1980
K874031 DIAGNOSTIC PRODUCTS CORP. IRMA-COUNT FERRITIN W/MONO. ANTIBODIES RKFE1,2,5 11/25/1987
K871489 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL 5400 ACTIVE (TM) FERRITIN EIA SYSTEM 06/12/1987
K841925 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL FERRITIN IRMA 05/25/1984
K133083 DIAZYME LABORATORIES DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET 06/24/2014
K935528 E.I. DUPONT DE NEMOURS & CO., INC. DUPONT ACA(R) PLUS IMMUNOASSAY SYS FERRITIN(FERR) METH 01/28/1994
K052617 GOOD BIOTECH CORP. FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510; FERRITIN CONTROLS, LEVEL-L & LEVEL-H, 02/23/2006
K812597 HYBRITECH, INC. FERRITIN KIT 10/19/1981
K863345 HYBRITECH, INC. TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAY 10/08/1986
K823871 HYBRITECH, INC. TANDEM-E -FER IMMUNOENZYMETRIC KIT 02/25/1983
K830580 IAGNON CORP. DIAGNON FERRITIN 125 I RIA KIT 05/05/1983
K883746 ICN MICROMEDIC SYSTEMS MICROMEDIC FERRITIN IRMA KIT 10/27/1988
K040879 INSTRUMENTATION LABORATORY CO. QUANTEX FERRITIN 05/10/2004
K952286 JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. AMERLITE FERRITIN II ASSAY 06/20/1995
K050944 KAMIYA BIOMEDICAL CO. K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET 12/23/2005
K014293 KAMIYA BIOMEDICAL CO. K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET 02/19/2002
K121232 KAMIYA BIOMEDICAL COMPANY K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR 05/24/2012
K822472 KENT LABORATORIES, INC. ANTISERA TO HUMAN FERRITIN 09/30/1982
K811880 LEECO DIAGNOSTICS, INC. LEECO FERRITIN-QUANT DIAG. TEST KIT 07/16/1981
K901075 LONDON DIAGNOSTICS, INC. LUMATAG(TM) FERRITIN CHEMILUMINESCENCE IMMUNOMET. 04/02/1990
K862960 MEDICAL & SCIENTIFIC DESIGNS, INC. PHASE II FERRITIN RADIOIMMUNOASSAY KIT 08/27/1986
K062746 MEDICON HELLAS S.A. FERRITIN-LATEX, MODELS 1418-2070, 1418-0279 11/20/2006
K896585 MEDIX BIOTECH, INC. MODIFIED FERRITIN ENZYME IMMUNOASSAY TEST KIT 12/04/1989
K920046 MEDIX BIOTECH, INC. MODIFIED FERRITIN ENZYME IMUNOASSAY TEST KIT 01/28/1992
K823275 MICROMEDIC SYSTEMS AUTOPAK FERRITIN TEST DELIVERY SYS 12/03/1982
K811808 MICROMEDIC SYSTEMS AUTOPAK-12 FERRITIN KIT 07/10/1981
K790490 NEW ENGLAND IMMUNOLOGY ASSOC. NEIA-FERRITIN ENZYMEIMMUNASSAY KIT 04/23/1979
K780490 NEW ENGLAND IMMUNOLOGY ASSOC. NEIA-FERRITIN ENZYMEIMMUNOASSAY 04/10/1978
K874572 NICHOLS INSTITUTE DIAGNOSTICS ALLEGRO (TM) FERRITIN IMMUNOASSAY SYSTEM 12/02/1987
K984186 NICHOLS INSTITUTE DIAGNOSTICS NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY 02/02/1999
K801989 NORDICLAB INTL. NORDICLAB FERRITIN IRMA TEST 09/16/1980
K963170 OLYMPUS AMERICA, INC. OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT 12/02/1996
K030124 OLYMPUS AMERICA, INC. OLYMPUS FERRITIN REAGENT 02/06/2003
K973331 Ortho-Clinical Diagnostics, Inc. VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340) 10/22/1997
K812056 RAMCO LABORATORIES, INC. SPECTRO FEIRITIN 08/12/1981
K000662 RANDOX LABORATORIES, LTD. RANDOX FERRITIN 04/03/2000
K053211 REFERENCE DIAGNOSTICS, INC. RDI HSFERRITIN KIT 03/13/2006
K100538 Roche Diagnostics TINA-QUANT FERRITIN GEN. 4 06/22/2010
K031650 ROCHE DIAGNOSTICS CORP. FERRITIN GENERATION 2 07/17/2003
K862014 SCLAVO, INC. IMMPULSE FERRITIN ASSAY REAGENT 06/19/1986
K970612 SEALITE SCIENCES, INC. SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY 06/24/1997
K884683 SERONO-BAKER DIAGNOSTICS, INC. FERRITIN SEROZYME IMMUNOENZYMETRIC ASSAY 12/27/1988
K911175 SERONO-BAKER DIAGNOSTICS, INC. SRI FERRITIN IMMOENZYMETRIC ASSAY(MAG SOLID-PHASE) 04/05/1991
K110736 Siemens Healthcare Diagnostics Inc. ADVIA CHEMISTRY FERRITIN (FRT) METHOD 08/17/2011
K171642 Siemens Healthcare Diagnostics Inc. Atellica IM Ferritin Assay 08/31/2017
K931576 SYVA CO. VISTA FERRITIN ASSAY 08/05/1993
K924858 TOSOH MEDICS, INC. AIA-PACK FER CALIBRATION VERIFICATION TEST SET 12/15/1992
K792449 UNION CARBIDE CORP. CENTRIA FERRITIN RIA 12/31/1979
K951993 UNITED BIOTECH, INC. UBI MAGIWEL FERRITIN QUANTITATIVE 07/05/1995
K790447 VENTREX LABORATORIES, INC. VENTRE/SEP FERRITIN RIA 04/23/1979
K920952 VITEK SYSTEMS, INC. VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY 04/07/1992


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